By Mike Montemarano, Associate Editor12.20.22
There are plenty of opinions about potential modifications to the Dietary Supplement Health and Education Act (DSHEA), which amended the Federal Food, Drug, and Cosmetic Act (FDCA) in 1994 to establish a new regulatory framework for dietary supplements.
For example, some stakeholders have called for changes to how structure-function claims are regulated, the drug preclusion clause, mandatory product listing, and more.
The intent of DSHEA, when it was proposed, was to avoid limiting access to information and products, said Gretchen DuBeau, executive and legal director at Alliance for Natural Health USA.
“FDA has prevented the public from accessing important information, especially over the last three years, with the agency preventing the dissemination of peer-reviewed scientific research on immune support,” DuBeau said. “We’re seeing censorship of the 4,000 peer-reviewed studies on vitamin D’s role in COVID-19 infections and severity, despite meta-analyses showing significant risk reduction. It’s not in the public’s best interest, and one of the most important changes we can make is to allow the free flow of information about the health benefits of dietary ingredients, specifically from MEDLINE-indexed publications.”
There are other examples of how restrictions on what a company can communicate may have a negative impact on consumers, DuBeau added. For instance, consumers might have limited data on dietary interventions they can make to lower blood cholesterol that is already in a healthy range, since FDA considers all cholesterol-related claims to be disease claims.
“Companies are restricted from sharing true, validated information,” DuBeau added. “Congress needs to better clarify their intent behind structure-function claims because FDA asserts that a claim which suggests a relationship between the presence of a nutrient and a health-related condition is an implied disease claim.”
The most recent example is FDA’s response to an NDIN for a beta-NMN ingredient. The agency initially responded positively to the NDIN, but backtracked and rejected the dietary ingredient’s legal status on FDCA’s drug preclusion grounds without providing data as to why, such as the date on which NMN was first approved for research as a new drug.
The drug preclusion clause poses bans on new dietary ingredients that “last forever, giving the drug industry a monopoly for any compound,” said Woodlee. “It’s imbalanced and there’s nothing that can reverse this ban. Look at other ingredients like NAC, CBD, and, going back, red yeast rice. There’s clearly an opportunity to make this more balanced for all parties, such as with fish oil. Drugs and supplements can coexist in their respective marketplaces if we clearly define the difference between a dietary supplement and a drug.”
The easiest fix would be to have Congress “clearly codify the concept that prior drug exclusion doesn’t apply to ingredients that were on the market before DSHEA was enacted,” Woodlee continued. “For now, the industry needs to constantly look over its shoulder at all of the information from every drug company so that they know what opportunities FDA will have to pull the rug out from under them again.”
Investigational New Drug (IND) approvals don’t expire, DuBeau noted. “A company can sit on one for indefinite amounts of time without researching the ingredient, but once FDA makes that determination, it’s permanent. There’s a form of vitamin B6 the industry is precluded from using even though there’s no actual drug made from it; the company pulled their IND. We’re losing important nutrients and we’ll likely see a lot more of these examples in the near future.”
For example, some stakeholders have called for changes to how structure-function claims are regulated, the drug preclusion clause, mandatory product listing, and more.
Information Access
At the American Herbal Products Association’s (AHPA) virtual Regulatory Congress in November, panelists discussed structural changes to DSHEA and FDCA they would consider to be the most fundamental.The intent of DSHEA, when it was proposed, was to avoid limiting access to information and products, said Gretchen DuBeau, executive and legal director at Alliance for Natural Health USA.
“FDA has prevented the public from accessing important information, especially over the last three years, with the agency preventing the dissemination of peer-reviewed scientific research on immune support,” DuBeau said. “We’re seeing censorship of the 4,000 peer-reviewed studies on vitamin D’s role in COVID-19 infections and severity, despite meta-analyses showing significant risk reduction. It’s not in the public’s best interest, and one of the most important changes we can make is to allow the free flow of information about the health benefits of dietary ingredients, specifically from MEDLINE-indexed publications.”
There are other examples of how restrictions on what a company can communicate may have a negative impact on consumers, DuBeau added. For instance, consumers might have limited data on dietary interventions they can make to lower blood cholesterol that is already in a healthy range, since FDA considers all cholesterol-related claims to be disease claims.
“Companies are restricted from sharing true, validated information,” DuBeau added. “Congress needs to better clarify their intent behind structure-function claims because FDA asserts that a claim which suggests a relationship between the presence of a nutrient and a health-related condition is an implied disease claim.”
Drug Preclusion ‘Ripe for Amendment’
According to Will Woodlee, general counsel to AHPA, amending the FDCA to require FDA to be more transparent about how it enforces drug preclusion policy is necessary. He also called for putting a time limit on how long a specific ingredient can be banned from New Dietary Ingredient Notifications (NDIN) based on prior research as a drug.The most recent example is FDA’s response to an NDIN for a beta-NMN ingredient. The agency initially responded positively to the NDIN, but backtracked and rejected the dietary ingredient’s legal status on FDCA’s drug preclusion grounds without providing data as to why, such as the date on which NMN was first approved for research as a new drug.
The drug preclusion clause poses bans on new dietary ingredients that “last forever, giving the drug industry a monopoly for any compound,” said Woodlee. “It’s imbalanced and there’s nothing that can reverse this ban. Look at other ingredients like NAC, CBD, and, going back, red yeast rice. There’s clearly an opportunity to make this more balanced for all parties, such as with fish oil. Drugs and supplements can coexist in their respective marketplaces if we clearly define the difference between a dietary supplement and a drug.”
The easiest fix would be to have Congress “clearly codify the concept that prior drug exclusion doesn’t apply to ingredients that were on the market before DSHEA was enacted,” Woodlee continued. “For now, the industry needs to constantly look over its shoulder at all of the information from every drug company so that they know what opportunities FDA will have to pull the rug out from under them again.”
Investigational New Drug (IND) approvals don’t expire, DuBeau noted. “A company can sit on one for indefinite amounts of time without researching the ingredient, but once FDA makes that determination, it’s permanent. There’s a form of vitamin B6 the industry is precluded from using even though there’s no actual drug made from it; the company pulled their IND. We’re losing important nutrients and we’ll likely see a lot more of these examples in the near future.”
